Cleared Traditional

K961663 - ELECTRIC SEAT LIFT CHAIR

K961663 is an FDA 510(k) clearance for ELECTRIC SEAT LIFT CHAIR, manufactured by Ken Kemmerer. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K961663 · Ken Kemmerer · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
56d
Days
Class 2
Risk

K961663 is an FDA 510(k) clearance for the ELECTRIC SEAT LIFT CHAIR. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Ken Kemmerer (Wilkes Barre Twp, US). The FDA issued a Cleared decision on May 29, 1996 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ken Kemmerer devices

FDA 510(k) Submission Details - K961663

510(k) Number K961663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1996
Decision Date May 29, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 16
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K961663.
INVACARE LIFT CHAIR
K002171 · Invacare Corp. · Aug 2000
TWO RIVERS POWER LIFT/RECLINE CHAIR
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PREVENT I
K973373 · The Buzzz Corp. · Feb 1998
TMR48
K953342 · Pride Health Care, Inc. · Sep 1995
TMR-670
K931349 · Pride Health Care, Inc. · Jul 1993
TREATMENT TABLE, MODEL #825-100
K930262 · Biodan Medical Systems, Ltd. · Mar 1993